Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Ipsen
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00630695
First received: February 27, 2008
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study


Condition Intervention Phase
Lymphocele
Drug: Lanreotide LP 90
Drug: Placebo lanreotide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Quantity of lymph collected by the drain [ Time Frame: D4 post operativly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prevention of lymphocele [ Time Frame: D15, D30 and M6 ] [ Designated as safety issue: Yes ]

Enrollment: 148
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lanreotide LP 90
Drug: Lanreotide LP 90
Lanreotide LP 90
Placebo Comparator: 2 Drug: Placebo lanreotide
Placebo

Detailed Description:

Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events.

Data will be compared in the 2 groups.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient (> 18 years),
  • Patient undergoing an axillary lymphadenectomy for breast cancer
  • Patient giving her agreement after being informed

Exclusion Criteria:

  • Patients that don't understand the trial
  • Type 2 diabetic patients
  • Cyclosporine treatment
  • Biliary lithiasis
  • Pregnancy or breast feeding
  • Allergic reaction to Lanréotide or same class treatments
  • Patient included in another trial within the last 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630695

Locations
France
Hôpital Mère Enfant- CHU de Limoges
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Ipsen
Investigators
Study Chair: Yves Aubard, MD, PhD University Hospital, Limoges
  More Information

No publications provided

Responsible Party: CHU de Limoges
ClinicalTrials.gov Identifier: NCT00630695     History of Changes
Other Study ID Numbers: 2007-003576-19
Study First Received: February 27, 2008
Last Updated: January 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Axillary lymphocele breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lymphocele
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cysts
Lymphatic Diseases
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014